Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on the SWEDEHEART Platform
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6,012
- 试验地点
- 1
- 主要终点
- Death, Myocardial infarction and major bleeding event
研究概览
简要总结
In this trial we test the hypothesis that PCI and bivalirudin is superior to heparin alone (according to local protocol) in reducing death, MI, and major bleeding in patients with NSTEMI or STEMI at 180 days (primary end point), treated with ticagrelor or prasugrel.
详细描述
The follow up of endpoints will be performed using SWEDEHEART and national registries. Follow up of primary endpoints and stroke will also be performed by telephone contacts with the patients or first degree relatives by a nurse phone call after 7 days and 180 days. The nurses will also accumulate hospital record information on these endpoints.
A central adjudication will be performed for all reported primary endpoints for the first 180 days follow up. Every site will prepare source documents for the event and send it to UCR for central adjudication by an independent committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of NSTEMI as judged by the physician in accordance with current guideline definitions (positive troponin) or, patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block.
- •PCI of culprit lesion is intended (therapeutic PCI, not primarily diagnostic PCI).
- •Treated with bolus dose of ticagrelor or prasugrel before start of PCI. See 2.6
- •Ability to provide informed consent
- •Age 18 years or older
排除标准
- •Previous randomization in the VALIDATE-SWEDEHEART trial.
- •Known terminal disease with life expectancy less than one year.
- •Patients with known ongoing bleeding
- •Patients with uncontrolled hypertension in the opinion of the investigator
- •Patients with known subacute bacterial endocarditis
- •Patients with known severe renal (GFR < 30 ml/min) and/or liver dysfunction
- •Patients with known thrombocytopenia or thrombocyte function defects
- •Any other contraindication for the study medications.
- •Heparin > 5000U Before arriving to PCI lab or > 3000 U given during angiography before randomization.
- •GpIIb/IIIa inhibitors have been given or are pre-planned to be given during the procedure.
研究组 & 干预措施
bivalirudin
bivalirudin as intravenous bolus of 0,75 mg per kilogram followed by an infusion of 1,75 mg per kilogram per hour
干预措施: bivalirudin (Drug)
heparin
unfractionated Heparin 5 000 IU/ml as intravenous bolus according to local practice
干预措施: Heparin (Drug)
结局指标
主要结局
Death, Myocardial infarction and major bleeding event
时间窗: 180 days
次要结局
- Time to restenosis(180 days)
- TIMI flow grade after PCI(180 days)
- Death, Myocardial infarction and major bleeding events in the subgroups NSTEMI and STEMI(180 days)
- Time to primary endpoints (death, myocardial infarction and major bleeding event)(180 days)
- Number of events where primary endpoints (death, myocardial infarction and major bleeding event) and stroke have been registered(180 days)
- Minor bleeding during index hospitalization(180 days)
- Number of events where primary endpoints (death, myocardial infarction and major bleeding event) have been registered in heparin subgroups (U/kg, groups with certain max ACT values etc)(180 days)
- Time to all-cause death or re-hospitalization with myocardial infarction(180 days)
- Time to stent thrombosis(180 days)
- Time to re-hospitalization with reinfarction(180 days)
- Time to target lesion revascularization(180 days)
- Time to re-hospitalization with heart failure(180 days)
- Heart failure and complications of PCI during index hospitalization(180 days)
- Time to target vessel revascularization(180 days)
- Length of index hospital stay(180 days)
- Bail-out use of GpIIb/IIIa(180 days)